Pharmaceutical Quality Congress Presentations
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Pre-Conference Workshop: Wednesday, June 14, 2017 | |
1:00 p.m. - 4:00 p.m. |
Data Integrity Problems on the Rise: Ensuring Quality through Data Integrity Leo Dodds, Principal Consultant, QuintilesIMS |
Day 1: Thursday, June 15, 2017 | |
9:00 a.m. - 9:45 a.m. |
FDA’s Quest for Quality (No Slides) Howard Sklamberg, Principal, Sklamberg Strategies LLC |
9:45 a.m. - 10:30 a.m. |
Susan Schniepp, Fellow, Regulatory Compliance Associates Inc. |
10:45 a.m. - 12:00 p.m. |
Data Integrity: A Structural Approach to Compliance John C. (Jack) Garvey, Principal, Chief Executive Officer, Compliance Architects® |
1:00 p.m. - 1:45 p.m. |
Top 5 Annual 483 Observations: The Cycle of Quality Susan Schniepp, Fellow, Regulatory Compliance Associates Inc. |
1:45 p.m. - 2:30 p.m. |
Quality Metrics: What Do You Have To Report Susan Schniepp, Fellow, Regulatory Compliance Associates Inc. |
2:45 p.m. - 3:30 p.m. |
PDA Quality Culture Assessment Pilot Program Denyse Baker, Senior Advisor of Scientific and Regulatory Affairs, PDA |
3:30 p.m. - 4:30 p.m. |
Ask The Experts: Real-World Advice on Running Quality Programs (No Slides) Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf |
Day 2: Friday, June 16, 2017 | |
9:00 a.m.-9:45 a.m. |
Creating a Quality Culture to Aid Risk Management Teresa Gorecki, Practice Lead, Compliance Architects® |
9:45 a.m.-10:30 a.m. |
Diving Deep – Understanding More of the Pharmaceutical Supply Chain in 2017 Gerard Pearce, Executive Vice President, SQA Services, Inc. |
10:45 a.m.-12:00 p.m. |
David Elder, EVP, Regulatory Compliance, Greenleaf Health LLC |